Develop Standard Operating Procedures Using IEST Recommended Practices
Learn how to write an effective standard operating procedure incorporating the fundamentals of IEST recommended practices. Effective SOP's will create a robust contamination control program in your cleanroom operations. Be prepared to write your compnay's standard operating procedure for the selection of cleanroom garments and gowning in your cleanrooms, a standard operating procedure for behavior in your cleanroom and a standard operating procedure for testing and monitoring your cleanroom.
Course outline Who should attend? Course materials
Instructor Next date and location
Course outline
- Best practices for SOP development
- Create a SOP that directs:
- How to write a SOP
- Review a SOP
- Approve a SOP
- Distribute a SOP
- Review and revise all SOP’s
- Harmonization with industry standards
- ISO 14644-5 Cleanrooms and Associated Controlled Environments – Operations
- FDA c GMP’s
- Development of Process Map of Cleanroom Operations
- Linear product flow
- Linear personnel flow
- SOP Content
- Header
- Company name
- Supersedes date
- Effective date
- Procedure number
- Procedure name
- Approval signatures and date
- Purpose
- Scope
- Definitions
- Applicable reference documents
- Procedure
- Specifications
- Materials and equipment
- Methods
- Diagrams, flow charts, Visuals
- Records and forms NOTE: Must link form to SOP.
- Corrective Action
- Preventive Action
- Change History
- Confidentiality and document control
- Compliance
- Changing SOP’s
- Describe areas of SOP to be changed
- Rationale for the change – what and why
- Validation data
- Temporary or permanent change
- Approval signatures and dates
- Training to SOP’s
- Review written SOP
- Written test to check for comprehension
- Performance of SOP
- Periodic review and assessment of efficacy and validity of SOP
- Continuous training and positive reinforcement of procedures and policies
- Continuous audits for compliance
- Continuous improvement through six sigma initiatives, etc.
- Continuous documentation of all activities.
- Workshop
- Create individual SOP’s on company template to:
- IEST-RP-CC003 – Cleanroom Garments and Gowning
- IEST-RP-CC027 – Cleanroom procedures, practices and policies
- IEST-RP-CC006 – Testing cleanrooms and environmental monitoring
Who should attend?
Information coming soon.
Course materials
- Copy of PowerPoint presentation in course binder
- Certificate of attendance for completion of CEUs
Continuing Education Units: .6 CEUs
Instructor
Next dates and locations
May 11, 2023
9:00 a.m. - 4:30 p.m. Central TIme
Intercontinental St. Paul Riverfront*
St. Paul, Minnesota
During ESTECH 2023
Click here to view registration information
*Virtual option also available.